Prevention of Delirium Among Elderly Patients With Hip Fr... | NCT03470662

Studies
Prevention of Delirium Among Elderly Patients With Hip Fractures

NCT03470662

Sponsor

Zhoupu Hospital, Pudong New Area, Shanghai, China

Status

Completed

Last Update Posted

Mar 20, 2018Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Delirium
Hip Fractures

Interventions

Care bundle

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Jun 30, 2017Actual

Completion Date

Sep 30, 2017Actual

First Submitted Date

Mar 7, 2018

First Submission Date that Met QC Criteria

Mar 18, 2018

First Posted Date

Mar 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2018

Last Update Posted Date

Mar 20, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaoxiao Zhou, Director of Orthopaedics Department, Zhoupu Hospital, Pudong New Area, Shanghai, ChinaPrincipal Investigator

Lead Sponsor

Zhoupu Hospital, Pudong New Area, Shanghai, ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Objective: To evaluate the effect of care bundle on prevention of delirium among elderly patients with hip fractures.

Methods: A prospective randomized case control study was performed for 80 patients (≥65 years) with hip fractures treated surgically according to their ages and the type of fractures from March 1th of 2017 to June 30th of 2017．There were 11 males and 69 females, with the age of (79.3±7.84) years. Confusion assessment method (CAM) was applied to diagnose delirium after surgery, the subjects were randomized divided into experimental group (n=43) and control group (n=37). The parameters next were recorded and analyzed, including age, gender, type of fractures, type of internal instrument, amount of bleeding, time between injured to surgery, time length of operation, type of operation, VAS, incidence of delirium, perioperative complications and adverse events.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental group	Experimental	Care bundle	Other: Care bundle
control group	No Intervention	routine care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Care bundle	Other	Care bundle	experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of delirium among elderly patients with hip fractures	study hypothesis: the incidence of delirium postoperatively in experimental group is lower compared with control group	3 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥65 years
with hip fractures
treated surgically

Exclusion Criteria:

<65 years
psychiatric history
ICU post-operation
refuse to join this study
have delirium pre-operation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhoupu Hospital Shanghai		Shanghai			China

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium
D006620	Hip Fractures

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided